BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 17530289 · Received August 12, 2023

    Report

    Report Number
    MW5137209
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    June 9, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED, INFORMATION ABOUT AN EVENT THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. HOWEVER, THE ISSUE REPORTED, WAS RELATED TO AN IMPLANTED PADDLE LEAD MANUFACTURED BY MEDTRONIC. THE INFORMATION RECEIVED STATED, THAT A PATIENT'S MEDTRONIC LEADS WERE REPLACED WITH BOSTON SCIENTIFIC LEADS, DUE TO FRAYED MEDTRONIC LEADS. SURGERY OCCURRED ON (B)(6) 2010. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049422 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown